CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 242 enrolled
Drug / intervention
Influenza Virus Vaccine +1 morebiological
Likely dose
Influenza Virus Vaccine 0.25 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00885105
NCT00885105Phase 3Completed
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Evaluation of Serologic Responses to Fluzone® in Infants ≥ 6 Months of Age Who Did or Did Not Receive Fluzone® Vaccine at 2 Months of Age

Sanofi Pasteur, a Sanofi Company·interventional·Posted Apr 21, 2009·Updated Apr 14, 2016

In Brief

A Phase 3 clinical trial evaluating Influenza Virus Vaccine for Influenza. Completed, enrolled 242 participants across 6 sites.

Detailed Summary

The study is to compare the 2 Groups with respect to antibody responses to inactivated influenza vaccine. Observational Objectives: * To describe the percentage of participants with protective Hemagglutinin (HAI) antibody titers to each of the 3 vaccine antigens in both study groups following each vaccination. * To describe the HAI geometric mean titer (GMTs) to each of the 3 vaccine antigens in both study groups following each vaccination. * To describe the safety of the 2005-2006 pediatric formulation of Fluzone® vaccine in both study groups.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 21, 2009
Enrollment StartOct 1, 2005
Primary CompletionJan 1, 2006
Study CompletionSep 1, 2007
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 17.2 years ago

Interventions

Influenza Virus Vaccinebiological

0.25 mL, Intramuscular

Influenza Virus Vaccinebiological

0.25 mL, Intramuscular